On January 31, 2014, the U.S. Food and Drug Administration (FDA) announced that it is investigating whether or not there is an increased risk of stroke, heart attack and even death in men taking FDA-approved testosterone-boosting products. Several products, such as AndroGel made by AbbVie, Inc. and Axiron made by Eli Lilly, have been approved by the FDA to be prescribed to men for strictly medical reasons such as low levels of the male hormone due to chemotherapy or a genetic problem. These testosterone drugs typically come in the form of gels, patches or injections. Despite their approval for medical uses only, the drugs have been widely prescribed by physicians for “off-label” uses to older men seeking to boost their sex drive or energy levels. Although drug manufacturers typically claim that they do not condone the use of their drugs in an off-label manner, there have been several highly-publicized cases showing that extensive off-label marketing of these drugs to physicians does occur and, in some instances, has been explicitly encouraged by the drug manufacturer. The FDA’s investigation seems to have been spurned by two recent studies that both came to the conclusion that men taking testosterone therapy have an increased risk for cardiovascular events such as strokes and heart attacks. One of the studies was published in the November 6, 2013 edition of the Journal of American Medical Association and found men treated with testosterone experienced an approximately 30% increased risk of death, heart attack or ischemic stroke.
The FDA will continue to investigate the apparent links between these testosterone drugs and cardiovascular events, but has warned physicians to consider whether the potential risks of these drugs outweigh their benefits for individual patients. The FDA is now seeking all reports of adverse events from physicians and has a website where physicians and patients can submit reports of adverse events and side effects caused by these drugs.
SUGARMAN’s personal injury and product liability lawyers have experience that spans decade in investigating and handling claims involving defective drugs and pharmaceutical products. Should you or a loved one have any questions about these testosterone-boosting products, our attorneys stand ready to answer questions by or on behalf of victims. Please fill out a Contact Form, call us at (617) 542-1000 or e-mail firstname.lastname@example.org.